Category: Drugs Advisories

The Food and Drug Administration (FDA) reminds all hospitals and healthcare providers to take extreme caution on the use of Favipiravir. The product has been observed to have teratogenic and embryotoxic effects in animal studies. Its use is contraindicated in known or suspected pregnancy.

The FDA advises the licensed physicians to confirm a negative pregnancy test before using Favipiravir in women with child-bearing potential. They should be advised to use or continue using effective contraceptive methods while in use and for another seven (7) days after taking the last dose. If pregnancy is suspected, discontinue its use.

Favipiravir is distributed in the sperm. Male patients should be informed of the risk associated on the use of the product. Instruct the patients to use the most effective contraceptive methods while using the product and for another seven (7) days after the last dose. Advise the use of condom and instruct not to have sexual intercourse with pregnant women.

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered product:

“Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, use of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

June 4, 2020 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1011 || Public Health Warning Against the Purchase and Use of the Following Unregistered Product “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

The Food and Drug Administration (FDA) advises the public against the use of the unregistered drug product:

Copper Nanopeptide I.V. Drip

FDA Post-Marketing Surveillance (PMS) activities has verified that the abovementioned drug product has not gone through the registration of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety, and efficacy. Therefore, use of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health product without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to use the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

Alcohol 70% Solution 1L

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, use of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

May 26, 2020 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-854 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Alcohol 70% Solution 1L

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

ISOPROPYL ALCOHOL 70% SOLUTION 4L

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, use of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

May 26, 2020 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-853 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Isopropyl Alcohol 70% Solution 4L

This is to inform the concerned stakeholders on the following amendment to FDA Advisory No. 2020-0781 entitled “Pilot Implementation of FDA eServices Portal for License to Operate (LTO) Application for Drugstores, RONPD, Drug Distributor, and Drug Traders”.

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

Cefradine Capsules

CSPC Amoxicillin Capsules

OTC Chlorphenamine Maleate Tablets

Rengongniuhuang Jiaxiaozuo Jiaonang

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

The Food and Drug Administration (FDA) reminds all hospitals and healthcare providers to take extreme caution on the use of Chloroquine or Hydroxychloroquine due to the risk of QT prolongation. The FDA has recorded a total of 30 cases of QT prolongation on the use of the said products from 23 March 2020 to 12 May 2020.1

Chloroquine and hydroxychloroquine should be used with caution in patients with congenital or documented acquired QT prolongation and/or those with known risk factors for QT prolongation such as:

Cardiac disease e.g. heart failure, myocardial infarction;

Pro-arrhythmic conditions, e.g. bradycardia (<50 bpm);

History of ventricular dysrhythmias;

Uncorrected hypokalemia and/or hypomagnesemia; and

During concomitant administration with QT interval prolonging agents e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics, and some anti-infectives (including Azithromycin) as this may lead to an increased risk for ventricular arrhythmias, and sometimes a fatal outcome.2,3

The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, monitoring of adverse drug reactions should be strictly implemented.

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

Procain 2% Maxi 100 mL

FDA Post-Marketing Surveillance (PMS) activities has verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, use of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health product without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

May 6, 2020 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-768 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Procain 2% Maxi 100 mL

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

OTC Lianhua Qingwen Jiaonang

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

May 6, 2020 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-767 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product OTC Lianhua Qingwen Jiaonang

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected batches of the subject product from the market. The details of the product are as follows:

The MAH pursued the voluntary recall of the drug product as a precautionary measure while its safety review by the European Medicines Agency (EMA) is still ongoing due to the potential risk of liver injury with symptoms such as tiredness, loss of appetite, abdominal pain, yellowing of the skin, darkening of the urine, nausea, and vomiting.

Ulipristal is a progesterone receptor modulator which is used for the pre-operative treatment or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal (as acetate) 5 mg Tablet (Esmya) is packed in an Alu-PVC/PVDC grey opaque duplex blister pack of 14 tablets
(box of 28’s and 84’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected batches of the drug product are instructed to discontinue further distribution, sale, and use. All patients currently taking the drug product are instructed to consult with their physician or healthcare provider about treatment options. Likewise, all consumers are advised not to purchase the affected product batches and may contact Zuellig Pharma Corporation at telephone number (632) 8405-5121 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holders on the affected batches of the subject products from the market. The details of the products are as follows:

The MAHs pursued the voluntary recall of the drug products due to the microbial sterility issue found in certain batches provided to Columbia. The concerned batches were also exported to the Philippines. Therefore, the stated batches present quality and safety concerns.

Methotrexate is indicated in the treatment of gestational choriocarcinoma, acute lymphoblastic leukemia, and symptomatic control of psoriaris. The above-mentioned drug products are packed in a 3 mL flint glass vial (box of 1’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected batches of the drug products are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product batches and may contact Multicare Pharmaceuticals Philippines, Inc. at telephone number (02) 8811-0636 or mobile no. +639178854954 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected lot of the subject product from the market. The details of the product are as follows:

The MAH pursued the voluntary recall of the drug product due to the out-of-specification results on the assay, osmolarity, and pH stability. Therefore, the stated lot presents quality, safety, and efficacy concerns.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lot and may contact Multicare Pharmaceuticals Philippines, Inc. at telephone number (02) 8811-0636 or mobile no. +639178854954 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lot are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected lots of the subject product from the market. The details of the product are as follows:

The MAH pursued the voluntary recall of the drug product due to the out-of-specification result on its assay observed in the 24th-month of its shelf-life. The assay of a drug product determines the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. Therefore, the stated lots present quality, safety, and efficacy concerns.

Chloramphenicol in otic solution is indicated for the topical treatment of bacterial infection of the external ear caused by pathogens which are sensitive to it. It is active against a wide range of Gram-negative and Gram-positive organisms. Chloramphenicol 5 mg/mL Otic Solution (Klorobiz) is packed in a 10 mL LDPE plastic bottle.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lots of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lots and may contact Pharmabiz Solutions, Inc. at mobile no. +639274121330 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lots are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected batches of the subject product from the market. The details of the product are as follows:

The MAH pursued the voluntary recall of the drug product due to the presence of the impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer) in the active pharmaceutical ingredient supplied or manufactured by SMS Lifesciences India Ltd., in India. Therefore, the stated batches present quality and safety concerns.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected batches of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product batches and may contact Littman Drug Corporation at telephone no. (02) 8696-3294 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected lot of the subject product from the market. The details of the product are as follows:

The MAH pursued the voluntary recall of the drug product due to the out-of-specification result on its assay observed during the 24th-month out of its three (3) years shelf-life. The assay of a drug product determines the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. Therefore, the stated lot presents quality, safety, and efficacy concerns.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lot and may contact Pharmabiz Solutions, Inc. at mobile no. +639274121330 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lot are not sold or made available in their localities or areas of jurisdiction.

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, use of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, use of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The use of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

All healthcare professionals and the general public are hereby warned by the Food and Drug Administration (FDA) that affected lots of the subject product are being recalled from the market. The details of the product are as follows:

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lots did not conform to the set specifications of assay test. The assay of a drug product determines the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. Therefore, the stated lots present quality and efficacy concerns.

Salbutamol is a selective ß2-agonist bronchodilator which provides short acting bronchodilation in reversible airways obstruction. It is indicated to rapidly treat asthma, bronchospasm, and reversible airways obstruction by widening the airways of the lungs in adults, adolescents, and children aged 2 to 12 years. Salbutamol (as sulfate) 2 mg/5 mL Syrup (Strawberry Flavor) is packed in a 60 mL amber glass bottle (box of l’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lots of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lots and may contact Interchemex Laboratories, Inc. at telephone number (02) 8829-7605 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lots are not sold or made available in their localities or areas of jurisdiction.

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Transparency Seal

A Transparency Seal, prominently displayed on the main page of the website of a particular government agency, is a certificate that it has complied with the requirements of Section 93. This Seal links to a page within the agency’s website which contains an index of downloadable items of each of the above-mentioned documents.